Wednesday, September 26, 2018

Warning Letter of the Week: It's 5 o'clock somewhere edition

Shared Space with Non-Drug Operations
In addition, our inspection revealed that you were operating a microbrewery in space shared with your contract testing laboratory where you test OTC drug products and components. You prepared and stored microbiology laboratory media in the same area you use to conduct brewery operations.

For example, our investigators observed a full fermenter located approximately ten feet from the space where media is prepared, warmed, and stored. A brewery employee was also preparing beer kegs in this area. In addition, laboratory test media, open beer bottles, and brewing materials were co-mingled within the same refrigerator.

These facility conditions pose unacceptable risks, including contamination of media during its preparation and compromised sample analyses. Conducting your testing operations in a space shared with a microbrewery is inappropriate and does not comply with CGMP. Your testing must be performed using facilities that are designed and controlled for drug laboratory testing.

What's wrong with mixing business and pleasure? (Answer: lots, in this case.)

1 comment:

Having being intimately involved in the beer industry, I do not understand how this place was able to obtain state and federal licenses for commercial brewing, unless they were not open yet and did not have approval, and then in that case you're technically allowed to do whatever.